FDA Recall
Open, Classified
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Recall: Z-2041-2020
·
Initiated April 3, 2020
Recall
- Recall Number
- Z-2041-2020
- Event Number
- 85475
- Firm
- Immersivetouch Inc
- FEI Number
- 3014833795
- Product Code
- LLZ
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- April 3, 2020
- Address
- 910 W Van Buren St, Ste 715, Chicago, IL, 60607-3573
Description
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Reason
Observed an internal repetitive software glitch in ImmersiveView.
Action
ImmersiveTouch, Inc., notified customers on 04/03/2020 via email titled "Notification of ImmersiveView 2.1 Update". The email informed the customers that the firm will update the software from version 2.1 to 3.0.
Distribution
The device was distributed in the state of Illinois only.
Quantity
2 units